Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

Bariatric Surgery Candidate Clinical Trial

— MARS GI  

Official title:

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695989
• Other study ID #: CP008
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2023
• Source: Levita Magnetics
• Contact: Vivian Soto
• Phone: +56958360507
• Email: CP008[@]levita.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)

Description:

Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Subject is at least 18 years of age
• Subject is scheduled to undergo elective laparoscopic procedure
• Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

• • Subjects with pacemakers, defibrillators, or other electromedical implants
• Subjects with ferromagnetic implants
• Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
• Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
• Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
• Subject is pregnant or wishes to become pregnant during the length of study participation
• Subject is not likely to comply with the follow-up evaluation schedule
• Subject is participating in a clinical trial of another investigational drug or device Prisoner or under incarceration

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cholecystolithiasis
• Cholelithiases
• Cholelithiasis
• Disease
• Gallstones
• Other Disease

Intervention

Device:
• Dual Robotic Arm Accessory (DRAA)
Dual Robotic Arm Accessory (DRAA)

Locations

Country	Name	City	State
Chile	Clinica Colonial	Santiago
Chile	Hospital Fach	Santiago
Chile	Hospital Tisne	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Levita Magnetics	The Cleveland Clinic

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events- Safety	Adverse events related to the device	30 days
Secondary	Rate that the Dual Robotic Arm Accessory (DRAA) is able to engage, move, and decouple with the Magnetic Surgical System as controlled by the surgeon	Ratio of successful attempts vs unsuccessful attempts	Surgery time
Secondary	Conversion rate to open surgery	Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization	Surgery time